1
Adapting Guidelines for Emergencies in the
Digital Age
Session 176, February 13, 2019
Maria Michaels, MBA, PMP, Public Health Advisor, Centers for Disease Control
& Prevention
Sharon Pacchiana, FNP, MSN, MHA, MMI, Principal Health Systems Analyst,
Health Informaticist, The MITRE Corporation
2
Maria Michaels MBA, PMP, Public Health Advisor
Centers for Disease Control & Prevention
Has no real or apparent conflicts of interest to report.
The findings and conclusions in this presentation are those of
the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
Conflict of Interest
3
Sharon Pacchiana, FNP, MSN, MHA, MMI, Principal Health
Systems Analyst, Health Informaticist
The MITRE Corporation
Has no real or apparent conflicts of interest to report.
Conflict of Interest
4
Adapting Clinical Guidelines for the Digital Age
Today’s Guideline Development and Implementation
A Multi-stakeholder Approach for a Future State That Helps
Overcome Current Challenges
Agenda
Use Case: Development of Clinical Decisions Support (CDS) for
Anthrax Emergencies
Overarching Anthrax Clinical Decision Support Development
Approach
Anthrax CDS Development and Lessons Learned
Role of Local Health Care Systems
Summary
5
Discuss the efforts led by CDC on Adapting Clinical
Guidelines for the Digital Age
Explore a new process for sharing guidelines that
translate scientific evidence into practice more easily,
quickly, accurately, and consistently
Enable rapid translation in support of emergency
preparedness and response
Learning Objectives
Describe the process, challenges, opportunities, and
lessons learned in developing CDS for anthrax
Identify the role of local health systems in integrating CDS
for non-routine biological exposures with their clinical
workflows and electronic health records (EHRs)
6
Imagine you are a health care worker in a community hospital and
have just been advised that you will be receiving patients exposed
to anthrax in a mass casualty event.
How would you respond as patients started showing up in your
emergency department?
You reached out to public health authorities to get guidance and
recommendations in real-time…
…but the recommendations are dozens of pages long, in prose.
Scenario
How do you ensure treatment consistent with clinical guidelines?
7
Now Imagine a Future…
Clinical guidelines are expressed as executable code-based
clinical decision support (CDS) that can be integrated into
EHR systems in real time
Guidelines expressed consistently across implementation
sites
Executability forces precision in guideline implementation
Reduced (or eliminated) redundant implementation
efforts across sites
8
Clinical Guidelines of the Future
9
Adapting Clinical
Guidelines for the
Digital Age
10
STUDY
ACTPLAN
DO
Ensure clinical guidelines are followed consistently
to improve public health outcomes
Feedback Loop
11
Today’s Guideline Development and Implementation
Long Implementation Time
Research
Results
Literature
Review
Guideline
Narrative
Develop Guidelines Interpret & Implement Guidelines:
Local Level
Performed by up to 95% of ~5500 hospitals
Interpret & Implement
Guidelines: Across
Health Systems
Performed by up to 82% of ~355,000 clinics
Meta-
analysis
https://dashboard.healthit.gov/quickstats/quickstats.php
12
Guideline authors
Health IT developers
Communicators
Clinicians
Patients / Patient Advocates
Medical Societies
Public Health Organizations
Evaluation experts
Standards experts
Clinical decision support developers
Clinical quality measure developers
Policy or technical support for
implementation
Integrating Stakeholder Groups
13
Adapting Clinical Guidelines for the
Digital Age
Problem: Long Lag Time,
Inconsistencies, and
Inaccuracies in Translation
Contributes to an average of 17
years for scientific evidence to
apply in patient care
Reason: Playing the
“Telephone Game”
Multiple translations of guidelines
add complexity, opportunity for
error, and variation across
sites/providers
Solution: Developing Tools
and Guidelines Together
Can help evidence apply to
patient care more easily, quickly,
accurately, and consistently
https://www.cdc.gov/ophss/WhatWeDoACG.html
14
Redesigning Guideline
Development and Implementation
CURRENT STATE PROPOSED FUTURE STATE
Guidelines
CDS
Patient Care
10s-100s of
translations
100s-1000s of
translations
Guidelines
Informatics
Communications
Implementation
Evaluation
Concurrent
guideline
development
and translation
& upfront
planning
Local Implementation
Patient Care
Inconsistent (or nonexistent)
feedback loop
Consistent feedback
loop
15
Translating Evidence to Executable
CDS
Knowledge
Level
Description Example
L1
Narrative
guideline
Guideline for a specific disease that is written in the format of a
peer
-reviewed journal article
L2
Semi
-
structured
Flow diagram, decision tree, or other similar format that describes
recommendations for implementation
L3
Structured
Standards
-compliant specification encoding logic with data
model(s), terminology/code sets, value sets that is ready to be
implemented
L4
Executable
CDS implemented and used in a local execution environment (e.g.,
CDS that is live in an electronic health record (EHR) production
system) or available via web services
16
Use Case:
Development of
CDS for Anthrax
Emergencies
17
Overarching CDS Development Approach
Develop Clinical Decision Support Artifact
Research
Results
Literature
Review
Meta-
analysis
Narrative
Guideline(s)
Level 1 (L1) Development
Test Artifact
Pilot with
synthetic data
Conduct clinical pilot
Structured Code
Level 3 (L3) Development
Internal Validation
Testing
Implementation Guide
Semi-Structured
Logic
Level 2 (L2) Development
Value Sets
Level 4 (L4) Development
Implement Artifact
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
18
Level 2 Semi-structured Representation
1. Identified
Pertinent
Guidelines
3. Assessed Guidelines
per
Defined Criteria
4. Assessed
Recommendation
Statement(s) to Derive
Artifact
2. Developed Skeletal Clinical
Flow to Visualize Guidelines &
Focal Areas
Anthrax Post-Exposure Prophylaxis (PEP) for Asymptomatic Patients
5. Documented Detailed Clinical Workflow
with Semi-structured Representation of
CDS
(initially narrowed to 7 guidelines)
(17 total)
(selected 5 guidelines)
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
19
Level 3 Iterative Development and
Testing
Based on L2 semi-structured logic and value sets,
Developed CDS code in the Clinical Quality Language (CQL)
representation for clinical concepts), such as order sets and alerts
Incrementally tested (test-driven development)
* Not the same
as those used in
synthetic pilot
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
20
1. Generated 100 synthetic patient records using
Synthea
Synthea
Synthea™ is an open-source tool for
generating synthetic patient records
Provides statistically and
demographically accurate patient medical
history records that are free from cost,
privacy, and security concerns
Level 3 Synthetic Pilot
2. Executed CDS CQL against patient records and record outputs
Main output was a potential order set plus potential alerts
All formatted as appropriate FHIR resources
3. Clinical SMEs evaluated CDS outputs
Compared treatment and alerts generated by CDS to the
documented clinical recommendations
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
21
Final Anthrax CDS for Anthrax Post-
Exposure Prophylaxis
Complex CDS
artifact with:
8 value sets
105 CQL
expressions
232
dependencies
1215 lines of
code
Detailed L2
Detailed L3
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
22
Anthrax CDS Published
Metadata
CQL
Built-in synthetic test
patients
Implementation
guide
Validation report
https://cds.ahrq.gov/cdsconnect/artifact/anthrax-post-exposure-prophylaxis
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
23
L2 & L3 Challenges & Recommendations
Appropriate model to represent
clinical concepts
>Use proper FHIR resources so that the L3 accurately
represents clinical concepts
Inability to use actual patient data
for testing
>Use methodology (e.g. Synthea) to generate random
patient records to test logic
Proper error tracking
>Have a sequential iterative process for development
and the ability to trace errors
Issue Recommendation
Uncertainty of or conflicting guidance >Involve guideline developers with the L2 team
Multiple overlapping guidelines
>Define a systematic process for evaluating each
guideline and recommendation
>Develop a skeletal clinical workflow chart to visualize
the interrelationships
Complex clinical guidance
>Develop detailed clinical flow chart with semi-
structured representation
L2/L3 must align
>Have a robust ongoing mechanism for communicating
between L2 and L3 teams
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
24
Critical Success Factors in Developing
Clinical Decision Support
Critical elements for developing guidance into semi-structured
and structured guidance, then executing it in clinical systems
2. Education to each on all aspects of the process to ensure a
foundational understanding of the entire CDS development
process
1. Continual involvement throughout the process as a team
Guideline creators
Clinical artifact developers
Technical artifact developers
Health care system personnel implementing artifact
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
25
Identify population health threats and prioritize CDS to address
these threats
Include multiple facilities in developing or selecting CDS for
population health emergencies
Follow a standardized method of implementing guidelines into
clinical workflows.
Incorporate artifact implementation for disaster responses into an
integrated delivery network
Pilot in a large-scale emergency preparedness exercise using a
simulation built into the test environments at a variety of sites with
multiple EHR platforms in order to determine if there are any
challenges to resolve for local implementation
Role of Local Health Care Systems
2019 The MITRE Corporation. ALL RIGHTS RESERVED. Approved for Public Release: 19-0459. Distribution Unlimited.
26
Clinical Guidelines of the Future
Contribute to the Adapting Clinical
Guidelines for the Digital Age
Implementation Guide
(http://build.fhir.org/ig/cqframework
/cdc-acg/index.html)
27
Maria Michaels, MBA, PMP
Centers for Disease Control and Prevention
maria.michaels@cdc.gov
(o) 404-498-0997
Sharon Pacchiana, FNP, MSN, MHA, MMI
The MITRE Corporation
spacchiana@mitre.org
(c) 703-209-5212
Please complete the online evaluation. Thank you!
Questions
28
NOTICE This information was produced for the U. S. Government
under Contract Number HHSM-5000-2012-00008I, and is subject to
Federal Acquisition Regulation Clause 52.227-14, Rights in Data-
General. No other use other than that granted to the U. S.
Government, or to those acting on behalf of the U. S. Government
under that Clause is authorized without the express written
permission of The MITRE Corporation. For further information,
please contact The MITRE Corporation, Contracts Management
Office, 7515 Colshire Drive, McLean, VA 22102-7539, (703) 983-
6000. (c) 2019 The MITRE Corporation.
29
Guidelines Related to Anthrax
Considered
Infection Control
Guidance for Protecting Responders’ Health During the
First Week Following A Wide-Area Aerosol Anthrax Attack
(2012)
Occupational Health Guidelines for Remediation Workers
at Bacillus anthracis-Contaminated Sites (2002)
Clearance Strategy for Environments Contaminated with
Bacillus anthracis (2012)
Guideline for Isolation Precautions: Preventing
Transmission of Infectious Agents in Healthcare Settings
(2007)
Medical Examiners, Coroners, and Biologic Terrorism: A
Guidebook for Surveillance and Case Management (2004)
Laboratory
Recommended Specimens for Microbiology and Pathology
for Diagnosis of Anthrax (2017)
Biosafety in Microbiological and Biomedical Laboratories
(2009)
Guidelines for Safe Work Practices in Human and Animal
Medical Diagnostic Laboratories (2012)
Prevention
CDC Guidance: Anthrax Vaccine Adsorbed (AVA)
Post-Exposure Prioritization (2013)
Use of Anthrax Vaccine in the United States:
Recommendations of the Advisory Committee on
Immunization Practices (ACIP) (2010)
Treatment
Prevention and Treatment of Anthrax in Adults:
Results of CDC Expert Panels (2014)
Special Considerations for Pregnant and Postpartum
Women (2014)
Pediatric Anthrax Management (2014)
Emergency Use Instructions (EUI) for Doxycycline for
Post-exposure Prophylaxis (PEP) of Anthrax (2017)
Emergency Use Instructions (EUI) for Ciprofloxacin for
Post-exposure Prophylaxis (PEP) of Anthrax (2017)
Mass Casualty
Clinical Framework and Medical Countermeasure Use
During an Anthrax Mass-Casualty Incident (2015)
Identifying Meningitis During an Anthrax Mass Casualty
Incident: Systematic Review of Systemic Anthrax Since
1880 (2016)
Yellow highlights = those guidelines
used (5 total)